MelanomaPhase 1/2THERAVACNCT01331915
Safety and Toxicity Study of Vaccination for Advanced Metastatic Melanoma Patients
A Phase 1/2 study testing Theravac in people with Melanoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease. The primary objective is to analyze the safety of the inreasing doses of vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Theravac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Oct 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cutaneous, uveal or mucosal melanoma.
- Melanoma must be metastatic. The origin of the primary could be cutaneous, uveal or mucosal and any metastatic stage is accepted, except if brain or leptomeningeal localizations are present, or if plasma LDH are elevated more than 1.5 normal upper values (see also below).
- HLA-A2 positive.
- The melanoma must express the tyrosinase gene (positive RT-PCR on a frozen pre-immune tumor sample) (see Appendix B).
- At least one measurable or non-measurable tumor lesion (see Section 8.1).
- Expected survival of at least 3 months.
Show all 15Show fewer
- Karnofsky performance scale ≥70 or WHO performance status of 0 or 1 (see Appendix C).
- Vital laboratory parameters should be within normal range, except for the following laboratory parameters, which must be within the ranges specified:
- Lab Parameter Range Hemoglobin ≥ 10 g/dl or ≥ 6,25 mmol/l Granulocytes ≥ 1,500/µl Lymphocytes ≥ 700/µl Platelets ≥ 100,000/µl Serum creatinin ≤ 2.0 mg/dl or ≤ 177 μmol/l Serum bilirubin ≤ 2.0 mg/dl or ≤ 34.2 μmol/l ASAT and ALAT ≤ 2 x the normal upper limits LDH ≤ 1.5 x the normal upper limit.
- Viral serology:
- HIV (human immunodeficiency virus): negative antibodies.
- HBV (hepatitis B virus): negative antigens; antibodies may be positive.
- HCV (hepatitis C virus): negative antibodies.
- Age ≥ 18 years
- Able and willing to give valid written informed consent
Who cannot join
- Previous treatment with more than one regimen of systemic chemotherapy, combined or not with non-specific immunotherapy such as interferon alpha or interleukins. Chemoimmunotherapy or radiotherapy must be stopped within the preceding 4 weeks (6 weeks for nitrosoureas and mitomycin C).
- Previous treatment with a vaccine known or likely to contain the Tyrosinase.A2 epitope YMDGTMSQV.
- Clinically significant heart disease (NYHA Class III or IV) i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias.
- Active immunodeficiency or autoimmune disease. Vitiligo is not an exclusion criterion.
- Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
Show all 11Show fewer
- Allergy to kanamycin (used in the preparation of the recombinant protein) or to any other aminoglycoside antibiotic.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc, Centre du Cancer
Brussels, Brussels Capital, 1200
Jean-François Baurain, MD, PhD, 0032 2 764 54 71, jean-francois.baurain@uclouvain.be
Jerome Degueldre, MSc, 0032 2 764 75 33, jerome.degueldre@bru.licr.org
About this study
Official title: Phase I/II Study of Therapeutic Vaccination With Escalating Doses of Theravac®, a Proteinic Vector Targeting Dendritic Cells Coupled to a Melanoma Antigen, in Patients With Advanced Metastatic Melanoma.
In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease.
The primary objective is to analyze the safety of the inreasing doses of vaccine.
The secondary objective is to document whether this vaccine can induce tumor regression in immunized patients.
Read the detailed description
There are three treatment cohorts and the inclusion of patients in governed by the dose-limiting toxicities in the previous cohort.
- the first three patients will receive a dose of 50 µg of Theravac®
- second cohort of three patients will receive a dose of 150 µg Theravac®
- the third cohort of three patients will receive a dose of 250 µg Theravac® and eventually a total of 14 patients will complete the step with the highest dose.
All the patients will receive four immunizations every three weeks in two intradermal sites and in two subcutaneous sites.
- Conditions
- Melanoma
- Being tested
- Theravac
- Keywords
- Metastatic Melanoma, Safety, Theravac vaccine, HLA-A2 typing, Tyrosinase.A2 gene expression
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheravacBiological
Three groups with three doses (50 - 150 - 250 mcg), four times every three weeks.
Injection: intradermally and subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Theravac | Experimental | Theravac® is a recombinant adenylate cyclase toxin from Bordetella pertussis that has been detoxified by mutation of its catalytic domain, and which has been coupled to the Tyrosinase.A2 epitope YMDGTMSQV. Receives: Biological: Theravac |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the safety and toxicity of increasing doses of Theravac® in patients with advanced metastatic melanoma
The toxicity will be assess after the treatment (3 months) for the first three patients of each group.
Measured: the first 3 months of treatment
To determine whether these immunizations result in a detectable immune response
PBMC will be obtained from the buffy-coat of 500 ml of venous blood or from 100 ml of venous blood collected before and after immunization.
Measured: Up to 24 weeks
Secondary outcomes (1)
To document whether this vaccine can induce tumor regression in immunized patients.
The NEW RECIST criteria when applicable. For patients with only non-measurable lesion(s) at study entry, tumor response will be assessed descriptively.
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Jean-François Baurain, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc, Centre du Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331915
- Sponsor's protocol ID
- LUC 09-003
- Other IDs
- 2009-014651-77, 2009
- Acronym
- THERAVAC
- Status last verified
- Oct 2012
- First submitted
- 20 Jan 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Therapeutic Vaccination With Escalating Doses of Theravac®, a Proteinic Vector Targeting Dendritic Cells Coupled to a Melanoma Antigen, in Patients With Advanced Metastatic Melanoma.
- ClinicalTrials.gov ID
- NCT01331915
- Acronym / sponsor ID
- THERAVAC / LUC 09-003
- Conditions
- Melanoma
- Keywords
- Metastatic Melanoma, Safety, Theravac vaccine, HLA-A2 typing, Tyrosinase.A2 gene expression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Institut Pasteur
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (estimated)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease.
The primary objective is to analyze the safety of the inreasing doses of vaccine.
The secondary objective is to document whether this vaccine can induce tumor regression in immunized patients.
Detailed description
There are three treatment cohorts and the inclusion of patients in governed by the dose-limiting toxicities in the previous cohort.
- the first three patients will receive a dose of 50 µg of Theravac®
- second cohort of three patients will receive a dose of 150 µg Theravac®
- the third cohort of three patients will receive a dose of 250 µg Theravac® and eventually a total of 14 patients will complete the step with the highest dose.
All the patients will receive four immunizations every three weeks in two intradermal sites and in two subcutaneous sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theravac | Experimental | Biological: TheravacTheravac® is a recombinant adenylate cyclase toxin from Bordetella pertussis that has been detoxified by mutation of its catalytic domain, and which has been coupled to the Tyrosinase.A2 epitope YMDGTMSQV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically proven cutaneous, uveal or mucosal melanoma.
- Melanoma must be metastatic. The origin of the primary could be cutaneous, uveal or mucosal and any metastatic stage is accepted, except if brain or leptomeningeal localizations are present, or if plasma LDH are elevated more than 1.5 normal upper values (see also below).
- HLA-A2 positive.
- The melanoma must express the tyrosinase gene (positive RT-PCR on a frozen pre-immune tumor sample) (see Appendix B).
- At least one measurable or non-measurable tumor lesion (see Section 8.1).
Key exclusion criteria (11 listed)
- Previous treatment with more than one regimen of systemic chemotherapy, combined or not with non-specific immunotherapy such as interferon alpha or interleukins. Chemoimmunotherapy or radiotherapy must be stopped within the preceding 4 weeks (6 weeks for nitrosoureas and mitomycin C).
- Previous treatment with a vaccine known or likely to contain the Tyrosinase.A2 epitope YMDGTMSQV.
- Clinically significant heart disease (NYHA Class III or IV) i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias.
- Active immunodeficiency or autoimmune disease. Vitiligo is not an exclusion criterion.
- Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheravacThree groups with three doses (50 - 150 - 250 mcg), four times every three weeks. Injection: intradermally and subcutaneously. | Biological | Theravac |
Primary outcome
To analyze the safety and toxicity of increasing doses of Theravac® in patients with advanced metastatic melanoma
Time frame: the first 3 months of treatment
The toxicity will be assess after the treatment (3 months) for the first three patients of each group.
To determine whether these immunizations result in a detectable immune response
Time frame: Up to 24 weeks
PBMC will be obtained from the buffy-coat of 500 ml of venous blood or from 100 ml of venous blood collected before and after immunization.
1 secondary outcome
To document whether this vaccine can induce tumor regression in immunized patients.
Time frame: at week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Baurain, MD, PhD principal investigator
Cliniques universitaires Saint-Luc, Centre du Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Theravac in people with Melanoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Baurain, MD, PhD (0032 2 764 54 71, jean-francois.baurain@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To analyze the safety and toxicity of increasing doses of Theravac® in patients with advanced metastatic melanoma (time frame: the first 3 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2012.